Brief Title
Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer
Official Title
Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop
tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who
have persistent or recurrent endometrial cancer.
Detailed Description
OBJECTIVES:
- Determine the antitumor activity of oxaliplatin in terms of response rate in patients
with persistent or recurrent endometrial carcinoma that is refractory to curative or
established therapy.
- Determine the nature and degree of toxicity of this treatment regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.
Study Phase
Phase 2
Study Type
Interventional
Condition
Endometrial Cancer
Intervention
oxaliplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
November 1999
Completion Date
September 2007
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed endometrial carcinoma that is refractory to curative therapy
or established treatment
- Clinically and/or histologically confirmed persistent or recurrent disease
- Measurable disease by physical examination or medical imaging
- Sonography allowed if lesions are clearly defined on initial examination and
bidimensionally measurable
- Ascites or pleural effusions not considered measurable
- Must have received 1 prior cytotoxic therapy regimen
- May include high-dose therapy, consolidation, or extended therapy after surgical
or nonsurgical assessment
- 1 additional noncytotoxic regimen allowed
- Biologic or cytostatic agents include, but are not limited to:
- Monoclonal antibodies
- Cytokines
- Small-molecule inhibitors of signal transduction
- Ineligible for a higher priority GOG protocol
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2 if received 1 prior therapy regimen
- GOG 0-1 if received 2 prior therapy regimens
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No symptomatic congestive heart failure, unstable angina pectoris, or cardiac
arrhythmia
Neurologic
- No sensory or motor neuropathy greater than grade 1
- No residual neuropathy attributed to prior chemotherapy or other chronic conditions
(e.g., diabetes, venous stasis, or carpal tunnel syndrome)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergy to platinum compounds or antiemetics
- No active infection requiring antibiotics
- No other uncontrolled illness
- No other invasive malignancies within the past 5 years except nonmelanomatous skin
cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 14 days since prior pegfilgrastim
- At least 24 hours since other prior growth factors
- At least 3 weeks since prior biologic or immunologic therapy
- No concurrent growth factors during first course of study therapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- No more than 1 prior cytotoxic chemotherapy regimen, either single or combination
cytotoxic drug therapy
- No prior oxaliplatin
Endocrine therapy
- At least 1 week since prior hormonal therapy directed at tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
Surgery
- Recovered from any recent surgery
Other
- At least 3 weeks since prior therapy for endometrial cancer
- No other concurrent investigational agents
- No prior anticancer therapy that would preclude study participation
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paula M. Fracasso, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00071929
Organization ID
CDR0000068235
Secondary IDs
GOG-0129K
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Paula M. Fracasso, MD, PhD, Study Chair, Washington University Siteman Cancer Center
Verification Date
September 2004